CAFCIT: Pharmaceutical manufacturers, suppliers, and distributors

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Hikma	CAFCIT	caffeine citrate	SOLUTION;INTRAVENOUS	020793	NDA	Hikma Pharmaceuticals USA Inc.	0641-6164-10	10 VIAL in 1 BOX (0641-6164-10) / 3 mL in 1 VIAL (0641-6164-01)	2008-11-04
Hikma	CAFCIT	caffeine citrate	SOLUTION;INTRAVENOUS	020793	NDA	Hikma Pharmaceuticals USA Inc.	0641-6267-10	10 VIAL in 1 BOX (0641-6267-10) / 3 mL in 1 VIAL (0641-6267-01)	2024-01-11
Hikma	CAFCIT	caffeine citrate	SOLUTION;ORAL	020793	NDA	Hikma Pharmaceuticals USA Inc.	0641-6164-10	10 VIAL in 1 BOX (0641-6164-10) / 3 mL in 1 VIAL (0641-6164-01)	2008-11-04
Hikma	CAFCIT	caffeine citrate	SOLUTION;ORAL	020793	NDA	Hikma Pharmaceuticals USA Inc.	0641-6267-10	10 VIAL in 1 BOX (0641-6267-10) / 3 mL in 1 VIAL (0641-6267-01)	2024-01-11
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: August 2, 2025

Introduction

Cafcit, a formulation comprising caffeine citrate, is a critical medication primarily used to treat apnea of prematurity, neonatal respiratory depression, and certain neurological conditions. As a specialty drug, the supply chain for Cafcit necessitates precise sourcing, manufacturing standards, and regulatory compliance. This report delineates key suppliers involved in the production of caffeine citrate, the raw materials, manufacturing entities, and distributors to enable stakeholders to understand the global supply landscape effectively.

Overview of Cafcit Supply Chain

Caffeine citrate (C₁₃H₁₈N₄O₁₄) is synthesized through multi-step chemical processes involving the procurement of raw materials such as caffeine, citric acid, and various intermediates. Manufacturers often rely on specialized suppliers with expertise in high-purity pharmaceutical-grade chemicals.

The supply chain spans:

Raw material suppliers
API (Active Pharmaceutical Ingredient) manufacturers
Finished dosage form producers
Distributors and logistics providers

Given its critical role in neonatal care, the integrity and reliability of supplier channels are paramount. The following sections detail the primary suppliers involved at each stage.

Raw Material Suppliers

1. Caffeine Raw Material Suppliers

Cognis (BASF)
- Overview: A leading chemical supplier, BASF's Cognis division has historically supplied pharmaceutical-grade caffeine for medicinal applications.
- Product Specifications: High-purity caffeine suitable for pharmaceutical formulation.
- Market Position: One of the largest global producers, with rigorous quality assurance for pharmaceutical standards.
FagronSelecta (Fagron)
- Overview: Fagron supplies pharmaceutical ingredients, including caffeine, sourced with compliance to pharmacopeia standards (USP, EP).
- Supply Focus: Customized formulations for compounding and manufacturing.
Merck KGaA (Sigma-Aldrich)
- Overview: Offers pharmaceutical-grade caffeine used in research, with some documentation for medicinal applications.
- Note: Usually used in R&D rather than direct medicinal formulations.

2. Citric Acid and Other Intermediates

Cargill
- Specializes in pharmaceutical-grade citric acid, a key component for citrate salts.
Roquette
- Supplies high-purity citric acid and related acids, ensuring compliance with pharmacopeia standards.

Active Pharmaceutical Ingredient (API) Manufacturers

The production of caffeine citrate involves chemical synthesis combining caffeine and citric acid derivatives. Due to the complexity, APIs are primarily produced by specialized manufacturers with strict GMP compliance.

1. Lonza

Overview: A global leader in custom manufacturing for pharmaceuticals, Lonza produces caffeine and citrate salts under GMP conditions.
Capabilities: Large-scale synthesis, rigorous quality control, and supply chain resilience.
Application: Supplies caffeine citrate APIs to pharma companies globally.

2. Zhejiang Medicine Co., Ltd.

Location: China
Overview: Manufactures caffeine citrate API with ISO-certified facilities. Plays a significant role in supplying Asian markets.
Quality: Complies with international pharmacopeial standards.

3. Taiyo Orange Co., Ltd.

Location: Japan
Overview: Specializes in synthesized caffeine citrate, with a focus on high-purity APIs for neonatal pharmaceuticals.

Finished Dosage Form Manufacturers

While multiple pharmaceutical companies produce caffeine citrate, only select firms manufacture Cafcit as a sterile injectable, especially in compliance with regulatory standards.

1. Hospira (a Pfizer company)

Status: Historically one of the primary producers of sterile caffeine citrate injections.
Market Position: Supplies to hospitals and clinics globally; however, manufacturing has limited options due to regulatory constraints.

2. APICX Pharma

Overview: A Chinese pharmaceutical company specializing in injectable caffeine citrate, with approvals in Asia, Latin America, and some European markets.
Regulatory Note: Vigilant compliance with WHO GMP standards.

3. Local/National Producers

Many countries have domestic producers compliant with their regulatory areas, but capacity and quality vary.

Distributors and Logistics Providers

Effective distribution hinges on pharmaceutical-grade cold chain logistics and regulatory compliance with import/export laws.

Major global pharmaceutical distributors such as McKesson, Cardinal Health, and local distributors handle licensing and distribution.
Specialized cold chain logistics providers, including DHL Medical Express and FedEx Custom Critical, ensure product integrity.

Regulatory and Quality Standards

Suppliers must adhere to stringent regulatory frameworks, such as:

United States Pharmacopeia (USP)
European Pharmacopoeia (EP)
Good Manufacturing Practice (GMP) standards

These ensure purity, stability, and efficacy of caffeine citrate used in Cafcit formulations.

Current Supply Dynamics and Challenges

Raw Material Constraints: Fluctuations in raw material availability, especially caffeine from natural sources such as coffee beans and tea leaves, can impact supply stability.
Manufacturing Capacity: Limited production capacity for sterile caffeine citrate injections constrains market supply, as the manufacturing process is complex, with high regulatory hurdles.
Geopolitical Factors: Trade restrictions and tariffs affect cross-border procurement, especially for suppliers in China, India, and Europe.
Quality Assurance: Increasing regulatory scrutiny demands rigorous documentation and validation, complicating the sourcing process.

Key Stakeholders and Their Roles

Stakeholder	Role	Noteworthy Attributes
BASF (Cognis)	Raw material supplier	Largest producer of pharmaceutical caffeine
Lonza	API manufacturer	GMP-compliant, global distribution capabilities
Zhejiang Medicine	API provider (China)	Cost-effective, high-volume API manufacturing
Hospira	Finished product manufacturer	Sterile caffeine citrate injection supply
Distributors	Logistics	Cold chain expertise, global reach

Conclusion

The supply chain for Cafcit, centered around high-quality caffeine citrate, involves a network of specialized raw material providers, API manufacturers, and finished dosage form producers with strict adherence to regulatory standards. Key suppliers like BASF and Lonza dominate the raw material and API markets, while regional manufacturers fulfill local demand, especially in Asia and Europe. Supply chain resilience continues to be challenged by capacity constraints, raw material scarcity, and regulatory demands, emphasizing the need for diversified sourcing strategies.

Key Takeaways

Trusted suppliers such as BASF and Lonza are critical for high-purity caffeine citrate, the core ingredient in Cafcit.
Regulatory compliance (GMP, pharmacopeial standards) is non-negotiable in sourcing pharmaceutical-grade caffeine citrate.
Geographic diversification minimizes supply risk, especially amid geopolitical and raw material sourcing constraints.
Limited manufacturing capacity for sterile caffeine citrate injections necessitates strategic procurement planning.
Supply chain transparency and quality assurance are essential for maintaining consistent access to Cafcit, particularly in neonatal critical care.

FAQs

1. Who are the leading global suppliers for caffeine citrate used in Cafcit?
BASF (through its Cognis division) and Lonza are the primary global suppliers of pharmaceutical-grade caffeine citrate, providing both raw materials and APIs that meet GMP standards.

2. What regulatory standards do suppliers of Cafcit need to comply with?
Suppliers must comply with GMP, USP, EP, and regional pharmacopeial requirements to ensure product safety, purity, and efficacy.

3. How does raw material sourcing impact the supply of Cafcit?
Dependence on natural sources for caffeine, along with geopolitical factors, can impact supply stability, necessitating diversified sourcing strategies.

4. Are there regional differences in Cafcit manufacturing?
Yes; Asian manufacturers, particularly in China and Japan, dominate API production, while specialized European and American firms manufacture finished sterile products, subject to regional regulatory approvals.

5. What are the major logistical challenges in distributing Cafcit globally?
Maintaining cold chain integrity, ensuring regulatory compliance during export/import, and managing lead times amidst capacity constraints are key logistical challenges.

References

[1] U.S. Pharmacopeia. (2022). Monograph: Caffeine.
[2] European Pharmacopoeia. (2022). Caffeine citrate monograph.
[3] BASF. (2023). Pharmaceutical Ingredients Portfolio.
[4] Lonza. (2023). API Production Capabilities.
[5] Zhejiang Medicine Co., Ltd. Reports.

Suppliers and packagers for CAFCIT

CAFCIT

Suppliers for the Pharmaceutical Drug: CAFCIT (Caffeine)